Job Information
Amgen Process Development Principal Scientist - Cambridge MA in Cambridge, Massachusetts
467705BR
Auto req ID:
467705BR
Company:
Amgen
Job Code:
Pharmaceutical Pharmaceutical
Job Description:
ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers . If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.
Process Development Principal Scientist
What you will do
Let’s do this. Let’s change the world. In this vital role you will join our Pivotal Drug Product Technologies group in Cambridge, MA. This group supports drug product commercial formulation development as well as formulation/fill/finish process development for Amgen’s Late-Stage biologics. The Principal Scientist will provide technical and project leadership while integrating information generated by functionally diverse teams to ensure success through the commercialization process.
Delivering progress reports and presentations to ensure management awareness and engagement of the status, progress, and future program and functional needs
Authoring and reviewing guideline documents, technical protocols, reports, product impact assessments, regulatory submissions, and developing responses to regulatory questions
Driving continuous improvement in the drug product development process through technological innovation and application of first principles in process engineering
Serving as subject matter expert and help drive standard methodologies and technical advancements
Serving as a Drug Product Team Lead of matrixed team to develop strategy in support of commercialization and life cycle management of Amgen’s pipeline
Managing a team of engineers and scientists to advance program and functional objectives
Expanding utilization of advanced IS systems to improve drug product design through faster data availability, using historical information, analyzing large data sets, and statistical analysis
Working effectively in a highly matrixed team environment to influence and inspire change, efficiency, and foster positive relationships
Ability to travel domestically and internationally up to 10% of the time.
Position Title:
Process Development Principal Scientist - Cambridge MA
Job Category:
Scientific Research & Development
Minimum Education Required:
Bachelors
City*:
Cambridge
Additional Qualifications/Responsibilities:
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The Scientific professional we seek is an individual with these qualifications.
Basic Qualifications:
Doctorate degree PhD OR PharmD OR MD and 2 years of Scientific experience OR
Master’s degree and 5 years of Scientific experience
OR
Bachelor’s degree and 7 years Scientific experience
Preferred Qualifications:
Advanced degree in Engineering, Pharmaceutics, Biotechnology, Material Science or related subject area
8+ years of experience in pharmaceuticals/biotechnology
5+ years of experience that includes elements of formulation and fill/finish process development, process characterization, technical transfers to manufacturing sites, and statistical design and analysis of experiments, and regulatory authoring
Technical leader with demonstrated results driving forward programs
Experience in drug product regulatory strategy, RTQs, and agency engagement
Knowledge of, and hands-on experience with, bringing new biotech products to market, across various dosage forms and device delivery systems
Experience with programming (e.g. Python, R, MATLAB) and database languages (e.g. SQL), as well as data visualization tools (e.g. Tableau, Spotfire, D3js)
Proficiency in at least one statistical software package (e.g. SAS, JMP or Minitab)
Experience participating and leading global multi-functional teams
Outstanding knowledge of formulation, aseptic processing and manufacturing of biotechnology products, vials, syringes, cartridges, devices, disposables, modeling, and the associated GMP/Device documentation and regulatory filings
Strong problem solving and effective multi-functional interpersonal skills
Willing and able to learn new technologies at a rapid pace
Salary Range
155,244.00 USD - 183,930.00 USD
State*:
Massachusetts
Salary Range:
$100,000